Guidelines for Developing and ESTRs Ready to Eat RTE

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Introduction iii, I Guidelines for Developing Good Manufacturing Practices GMPs. and Standard Operating Procedures SOPs for Ready to Eat RTE Products1. 1 Good Manufacturing Practices GMPs 4,2 Standard Operating Procedures SOPs 9. II Guidelines for Environmental Sampling Testing Recommendations. for Plants Producing Ready to Eat Products 13, 1 Recommended Approach to Environmental Microbial Sampling 15. 2 Description of Laboratories Procedures 19, This is not a regulatory document These recommendations were developed by industry represenatives for producers of RTE. products to use to develop plant specific GMPs and SOPs. INTRODUCTION, Ready to Eat RTE meat products are important convenient meat food products They are widely.
distributed and consumed as snack foods sandwich fillings picnic items deli buffet foods and in. lots of other ways without any further food preparation They are a truly convenient food for. millions of consumers and they are presumed to be safe to eat by consumers as purchased. Certain strains of Listeria species a microorganism that exists widely in the environment have. been found to be pathogenic to the human population as well as to the animal population Listeria. spp unlike most other pathogens continues to grow albeit slowly under refrigerated conditions. The heat processing of RTE products destroys these bacteria however extraordinary handling. practices after cooking are needed to prevent recontamination Such handling is particularly. important to prevent recontamination with Listeria spp because they will continue to grow even. when the product is vacuum packed and held under refrigerated conditions. Detection of pathogenic microorganisms at very low levels on product is always difficult it s even. more difficult if they occur sporadically and the distribution is likely to be sporadic in. recontamination circumstances i e not uniformly distributed Aggressive preventive strategies are. the best way to assure the safety of RTE products coupled with an environmental microbiological. sampling and testing program to identify and eliminate any possible entry opportunities for this. family of microorganisms when RTE products are being handled and or packaged. A group of organizations sponsored the development of these Guidelines for Good Manufacturing. Practices GMPs Standard Operating Procedures SOPs and Environmental Sampling and. Testing Recommendations ESTRs for Ready to Eat Products Operational personnel from firms. producing RTE products met with Dr Kerri Harris for a working group session to develop the. GMPs and SOPs that are set forth herein In addition a group of industry microbiologists met. with Dr John Blackwell to develop the ESTRs that are set forth herein All persons who provided. their time and energy in this project are acknowledged herein. Facilitators Dr Kerri Harris Institute of Food Science Engineering Texas A M University. College Station TX and Dr John Blackwell Food Marketing Services International Inc Columbia. Participating Organizations American Association of Meat Processors North American Meat. Processors Central States Meat Association South Eastern Meat Association Southwest Meat. Association Food Marketing Institute and National Meat Association. Participating Microbiologists Dr Steve Goodfellow Deibel Laboratories Mike Craig ABC. Research Corp Ken Kenyon Deibel Laboratories Gina Bellinger IDEXX Laboratories Dr Margaret. Hardin National Pork Producers Council, Participating Individuals Bruce Barry Oberto Sausage Co Kent WA Chris Bodendorfer Emmpak. Foods Inc Troie Burch Quik to Fix Dallas TX Dr Robert Delmore Clougherty Packing Co Los. Angeles CA Dr Jill Hollingsworth Food Marketing Institute Jason Jennings Jennings Premium. Meats New Franklin PA Teresa Frey and Rosemary Mucklow National Meat Association Fred. Reimers H E Butt Grocery San Antonio TX Jonathan W Rocke RMH Foods Morton IL Sereke. Jim Tecklu International Trading Corp Houston TX Tim Wampler Elm Hill Meats Lenoir City. This is not a regulatory document These recommendations were developed by industry represenatives for producers of RTE. products to use to develop plant specific GMPs and SOPs. Guidelines for Developing,Good Manufacturing Practices GMPs. and Standard Operating Procedures SOPs,for Ready to Eat RTE Products. coordinated by Dr Kerri Harris Associate Director, The Institute of Food Science and Engineering College Station Texas. INTRODUCTION, Producers of ready to eat RTE products understand the importance of developing and.
implementing procedures to reduce the potential for contamination with microorganisms such as. Listeria monocytogenes Therefore it is extremely important that manufacturers of RTE. products develop and implement effective Good Manufacturing Practices GMPs and Standard. Operating Procedures SOPs as the foundations of a successful HACCP program Combining. strong GMPs SOPs SSOPs and HACCP will increase the total process control system and help. these manufacturers continue to produce the safest products possible The development and. successful implementation of these programs requires full management support and commitment. This document provides general recommendations for developing GMPs and SOPs for RTE. operations and it can be used as a guideline for developing plant specific GMPs and SOPs It. also addresses the issues of reprocessing product and recommendations for effectively using. environmental testing for Listeria species These recommendations focus solely on the RTE. products It is important to note that the following items are not addressed in detail in this. document but they should be covered by existing Sanitation Standard Operating Procedures. SSOPs or other plant specific processing programs, Personnel disease control hygiene clothing training etc. Plant and grounds construction and design product flow drainage etc. Sanitary operations general maintenance cleaning and sanitizing pest control etc. Sanitary facilities and controls water supply plumbing sewage disposal rubbish and. offal disposal etc, Freezers and coolers monitored and maintained to ensure temperature control recording. devices alarms etc, Equipment maintenance and calibration adequate frequency for thermometers recording. devices compressed air equipment etc, Recall program It is recommended that all RTE facilities develop a recall program and. that mock recalls should be conducted periodically to ensure that the program works as. Many of the items listed above are also addressed in 21 CFR Part 110 Current Good. Manufacturing Practice in Manufacturing Packing or Holding Human Food developed by the. Food and Drug Administration and can be used as a resource if more information on any of these. areas is needed, This is not a regulatory document These recommendations were developed by industry represenatives for producers of RTE.
products to use to develop plant specific GMPs and SOPs. Ready to Eat RTE Products are perishable refrigerated frozen items such as luncheon. meats frankfurters cooked patties and other fully cooked products and meals that do not require. further heating before consumption Therefore it is important that appropriate heat treatments are. applied and that all possible steps are taken to reduce potential contamination after the heat. treatment or post processing It should be noted that each processor must validate the cooking. process for these products and meals as part of the HACCP development and implementation. Validation will ensure that the cooking process is adequate to control Listeria All of these actions. will help manufacturers of RTE products produce the safest products possible. All RTE operations should have a lotting mechanism for coding or recording finished products to. allow for tracing the product back through the system and for tracing the product forward. through the chain Some establishments may develop computerized bar codes or tracking. systems that are very elaborate and detailed and others may have simple handwritten. documentation and box package codes Lotting is driven by some time factor i e hour shift. day etc and is given a specific code Creating smaller lots or utilizing a sub lotting system for. tracking information may help demonstrate document process control and could possibly help to. minimize the economic impact of recalls, Regardless of the mechanism each operation should have a record keeping system and it is. recommended that the following items be documented for each identified lot sub lot. Raw material source s by vendor and including vendor lot identification. Data collected during process temperatures microbial data etc. Equipment evaluation records i e maintenance records. Other items as specified by individual customer, If any abnormal indicator is found during the process then it is recommended that the product be. segregated that cleaning and sanitizing of the processing line is completed prior to reinitiating. production and that a new lot sub lot is started when production starts back up Some. operations are implementing a sublotting system that requires the following types of. documentation, Batching records These records should identify the types of raw material used by. its tracking codes the amount used in each batch of formulated product the time it. was used and the locations of equipment it was used on. Packaged product tracking systems The finished products should be coded with. the actual times they are packed and sealed and pallets of products should contain. consecutive products off the line Packaging systems with multiple lines should have. a consistent flow of raw materials to each packaging line and the ability to code and. identify products from a specific line as necessary Downtime tracking sheets can be. used to identify lines that were not packaging products at the time of suspect. incidents and therefore created a break in the flow of products through the system. Finished Product On Hold Programs If a company is testing finished RTE. products for potential microbial adulterants then it should require appropriate. product lot s to be held until laboratory testing is completed and the results are. available Records for operations should include the total amount of products. This is not a regulatory document These recommendations were developed by industry represenatives for producers of RTE. products to use to develop plant specific GMPs and SOPs. produced as well as their location However it should be noted that end product test. and hold programs are not generally recommended,REPROCESSING PRODUCT. As with most production systems the issue of allowing products that do not meet the company. specifications broken ends and pieces leakers etc to re enter the system is an important. factor that must be considered Therefore the following categories are recommended to help. distinguish between the types of reprocessing activities that may occur during the production of. RTE products, 1 Recooking This allows products that have received the heat treatment but that do not.
meet the operational specifications to go through the heat treatment again These. products may be recooked as they are if the product allows it or they may be re. introduced into the system within the acceptable USDA guidelines For example items. Do not meet the production specifications i e mis sliced broken ends and pieces. leakers pinholes products that do not meet the sensory evaluation etc. Do not meet the CCP for heat treatment,Do not meet the cooling requirements. 2 Repackaging This allows product that has received the heat treatment but that does. not meet the operational specifications leakers coding film labels etc to be repackaged. without receiving an additional heat treatment These products must still be within the. post heat treatment processing area i e processing room chiller packaging room After. products leave the post heat treatment production environment the products should not. be allowed to be repackaged and must re enter via recooking as described above. 3 Returned and reinspected product It is recommended that RTE products that are. returned not be repackaged or redistributed until the establishment can evaluate and. document the safety of the product handling since it left the facility and the product. integrity has been maintained For example if product was inadvertently loaded onto a. truck and remained on the truck throughout the delivery route at an appropriate. temperature and was then returned at the end of the delivery then the establishment may. allow this product to be returned to available inventory. It should also be noted that unprotected RTE products that fall onto the floor must be discarded. They cannot be reprocessed and or reconditioned to reenter the food supply. The recommendations provided above should help an establishment make decisions relating to. the reprocessing of products Each establishment will need to carefully consider the options and. determine which one works best within their operation based on amount of production. opportunities for further processing etc Each establishment is encouraged to develop specific. written procedures for how it will handle these issues. This is not a regulatory document These recommendations were developed by industry represenatives for producers of RTE. products to use to develop plant specific GMPs and SOPs. GOOD MANUFACTURING PRACTICES, Good Manufacturing Practices GMPs as defined by the Food and Drug Administration in 21. Food Marketing Institute National Meat Association and Some establishments may develop computerized bar codes or tracking systems that are very elaborate and detailed and others may have simple handwritten documentation and box package codes Lotting is driven by some time factor i e hour shift day etc and is given a specific code Creating smaller lots or utilizing a sub

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